U.S. Rep. Ed Markey, D-Mass., speaks at a news conference outside the New England Compounding Center in Framingham, Mass., Thursday, Nov. 1, 2012. Markey outlined a plan to more closely regulate compounding pharmacies like the NECC which is linked to a deadly nationwide meningitis outbreak. / AP Photo

Written by

Paul C. Barton

Tennessean Washington Bureau

WASHINGTON — As Congress prepares for hearings on meningitis-related deaths and illness tied to a compounding pharmacy, some observers wonder if lawmakers will raise all of the right questions, including why compounders get so much drug business in the first place.

The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee convenes its inquiry on Wednesday, followed by the Senate Health, Education, Labor and Pensions Committee on Thursday.

They are both probing what could have prevented the recent onslaught of fungal meningitis cases caused by contaminated steroid drugs coming from the New England Compounding Center in Framingham, Mass.

So far, 438 people have been infected in 18 states, causing 32 deaths. Tennessee has had 81 cases, second only to Michigan’s 128. But no state has seen more deaths related to the drugs than Tennessee, with 13.

As hearings start, said Coral Gables, Fla., trial attorney Gary Alan Friedman, representatives and senators should be asking: Is all of this compounding really necessary?

Not getting the attention it deserves, he said, is the background role played by the major pharmaceutical companies that produce the off-the-shelf drugs that large-scale compounders — such as NECC — often mix to produce the customized pharmaceuticals many patients need.

Friedman believes the major pharmaceutical companies, which operate under much stricter regulation and quality-control standards, could be producing many of the drugs that come from compounders but don’t want to because it means going through extra regulatory hoops with the U.S. Food and Drug Administration.

“It’s really inexcusable. There is no reason for any of this to be happening,” Friedman said.

Instead, he claims, the major pharmaceutical companies have a financial incentive to sell mass quantities of their off-the-shelve drugs to large-scale compounders — like NECC — and let them do the mixing.

“They do it with kind of a wink and nod,” Friedman said of the major drug makers.

The lobbying group for major drug companies, the Pharmaceutical Research and Manufacturers Association of America, said in a statement late Monday:

“Patient safety is the priority for America’s innovative biopharmaceutical companies. Safety should always be at the forefront of the development, manufacturing and delivery of medicines, and biopharmaceutical research and manufacturing companies are rightly subject to rigorous pre- and post-approval safety standards set by the FDA.”

It added: “The compounding company identified in the recent meningitis outbreak is not an FDA-regulated manufacturer, although the scope of this company’s distribution of compounded products would seem to require consistent regulation to allow for the best possible care and safety of patients.”

The statement did not directly address Friedman’s concerns.

Congress, Friedman said, should examine the FDA approval process so that major pharmaceutical companies have more interest in making some of the products left to compounders.

While following the meningitis cases, Friedman himself has been busy representing clients who have gone blind and experienced other problems after receiving contaminated doses of the drug Avastin from compounders.

Although normally a cancer drug, Avastin in these cases was being used to combat macular degeneration. It is the type of specialized, “off-label” use of a drug that major drug manufacturers don’t want responsibility for, Friedman claims.

Some of the defendants in cases recently brought by Friedman in Florida include the drug-store chain Walgreens, a compounder and distributor; InfuPharma, a Florida compounder; and Genentech Inc., a major drug manufacturer.

Patients, he added, often have no idea that so many parties are involved in supplying their medicines.

Meanwhile, other observers say Congress needs to get a handle on the size and shape of the compounding industry. Since the meningitis outbreak started, various figures in the thousands have been bandied about to describe just how many compounders there are.

“I don’t think anybody has any good numbers on this,” said Allan Coukell, specialist on medical issues for the Pew Charitable Trusts.

“The real challenge is coming to grips with how this industry has grown and changed over the years.”

And since both state governments and the FDA claim jurisdiction over companies like NECC, Congress needs to examine how well state and federal regulators communicate with each other and coordinate their oversight.

Also, “we need to look very carefully at what quality control standards are in place,” Coukell said.

Meanwhile, Michael Carome, who tracks medical issues for the watchdog group Public Citizen, said the FDA has a lot to answer for in these hearings.

Carome has argued that the FDA, under Depression-era legislation, already has all the authority it needs to regulate compounders such as NECC.

What Congress needs to ask, he said, is what kind of follow-up there was after the FDA first started issuing warnings to NECC about its compounding processes in 2005.

“I think they need to focus on where the failure occurred,” Carome said. “Until then, it’s premature to jump in with new laws and regulations.”